MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Subject id: (b)(6).Study:dots.Clinical notification received for revision of right hip to address metallosis: date of implantation: (b)(6) 2002, date of revision: (b)(6) 2020 (right hip).Treatment: revision of head and liner products.Update: medical records received on (b)(6) 2020 were reviewed on (b)(6) 2020 by a clinician to identify patient harms/product issues.Doi: (b)(6) 2002: patient received a right pinnacle/srom mom to treat pain and dysfunction secondary to osteoarthritis.Intraoperatively, the surgeon notes there was femoral head arthrosis, mild synovitis, and significant calcification of the labrum.The patient received a pinnacle cup, metal ultamet liner, cocr head, ztt sleeve, and srom stem.The procedure was completed without complications.Clinic note dated (b)(6) 2020: patient presents with right hip pain.Radiology reports reveal that the cup is vertical.The surgeon suspects metallosis and schedules the patient for a revision of the right hip.Dor: (b)(6) 2020: patient received a total revision of the right hip to treat pain secondary to suspected armd.Upon entering the joint, the surgeon identifies and excises scar tissue and a pseudocyst.The cup was well-fixed but vertical, and revised.The stem and sleeve were well-fixed but revised.There was no wear identified on the revised metal liner.The head had some trunnionosis, but no evidence of wear, and was revised.The surgeon notes there was no metallosis in the joint and no pseudotumor present.The patient was revised with depuy products.The procedure was completed without complications.Doi: (b)(6) 2020, dor (b)(6) 2020, right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.X-ray images have been reviewed and the reported allegation of a mispositioned cup can be confirmed.The root cause could not be confirmed.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.The reported explant date in the initial report is now being retracted as the device was not revised.

Event Description

Dor: (b)(6) 2020: patient received a total revision of the right hip to treat pain secondary to suspected armd.Upon entering the joint, the surgeon identifies and excises scar tissue and a pseudocyst.The cup was well-fixed but vertical, and revised.The stem and sleeve were well-fixed but revised.There was no wear identified on the revised metal liner.The head had some trunnionosis, but no evidence of wear, and was revised.The surgeon notes there was no metallosis in the joint and no pseudotumor present.The patient was revised with depuy products.The procedure was completed without complications.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10548069
• MDR Text Key: 207406331
• Report Number: 1818910-2020-20382
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINN MAR +4 NEUT 36IDX52OD; PINNACLE 100 ACET CUP 52MM; S-ROM M HEAD 36MM +0; SROM SLEEVE; SROM*STM ST,30+4L NK,16X11X150; UNKNOWN HIP ACETABULAR CUP; PINN MAR +4 NEUT 36IDX52OD; PINNACLE 100 ACET CUP 52MM; S-ROM M HEAD 36MM +0; SROM SLEEVE; SROM*STM ST,30+4L NK,16X11X150; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 69